CL2019003143A1 - Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso. - Google Patents

Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso.

Info

Publication number
CL2019003143A1
CL2019003143A1 CL2019003143A CL2019003143A CL2019003143A1 CL 2019003143 A1 CL2019003143 A1 CL 2019003143A1 CL 2019003143 A CL2019003143 A CL 2019003143A CL 2019003143 A CL2019003143 A CL 2019003143A CL 2019003143 A1 CL2019003143 A1 CL 2019003143A1
Authority
CL
Chile
Prior art keywords
methods
antigen
combination
stable formulations
programmed death
Prior art date
Application number
CL2019003143A
Other languages
English (en)
Spanish (es)
Inventor
Chakravarthy Nachu Narasimhan
Soumendu Battacharya
Arnab De
Manoj K Sharma
Xiaoyu Yang
Rubi Burlage
Jason K Cheung
Original Assignee
Merck Sharp & Dohme
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of CL2019003143A1 publication Critical patent/CL2019003143A1/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CL2019003143A 2017-05-02 2019-10-30 Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso. CL2019003143A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762500268P 2017-05-02 2017-05-02

Publications (1)

Publication Number Publication Date
CL2019003143A1 true CL2019003143A1 (es) 2020-03-20

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2019003143A CL2019003143A1 (es) 2017-05-02 2019-10-30 Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso.

Country Status (17)

Country Link
US (2) US20200262922A1 (fr)
EP (1) EP3618866A4 (fr)
JP (2) JP2020518598A (fr)
KR (1) KR102624564B1 (fr)
CN (1) CN110678199B (fr)
AU (1) AU2018263837B2 (fr)
BR (1) BR112019022695A2 (fr)
CA (1) CA3060695A1 (fr)
CL (1) CL2019003143A1 (fr)
CO (1) CO2019012143A2 (fr)
EA (1) EA201992526A1 (fr)
MA (1) MA50501A (fr)
MX (1) MX2019013034A (fr)
SG (1) SG11201910134SA (fr)
TN (1) TN2019000294A1 (fr)
UA (1) UA129862C2 (fr)
WO (1) WO2018204343A1 (fr)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3222634A1 (fr) 2007-06-18 2017-09-27 Merck Sharp & Dohme B.V. Anticorps dirigés contre le récepteur humain de mort programmée pd-1
CN109180815B (zh) 2012-11-20 2022-06-21 赛诺菲 抗ceacam5抗体及其用途
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
JP6992068B2 (ja) 2016-12-07 2022-02-03 アジェナス インコーポレイテッド 抗ctla-4抗体およびそれらの使用方法
US20200354453A1 (en) * 2017-05-02 2020-11-12 Merck Sharp & Dohme Corp. Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
MA50501A (fr) * 2017-05-02 2020-09-09 Merck Sharp & Dohme Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation
EP3618871A4 (fr) 2017-05-02 2021-01-06 Merck Sharp & Dohme Corp. Formulations d'anticorps anti-lag3 etco-formulations d'anticorps anti-lag3 et d'anticorps anti-pd-1
CA3090996A1 (fr) * 2018-02-13 2019-08-22 Merck Sharp & Dohme Corp. Methodes de traitement du cancer avec des anticorps anti pd-1 et des anticorps anti ctla4
JP7467438B2 (ja) 2018-10-18 2024-04-15 メルク・シャープ・アンド・ドーム・エルエルシー 抗rsv抗体の製剤及びその使用方法
WO2020092233A1 (fr) 2018-10-31 2020-05-07 Merck Sharp & Dohme Corp. Anticorps anti-pd-1 humain et procédés d'utilisation associés
WO2020097141A1 (fr) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Formulations stables d'anticorps du récepteur de mort programmé 1 (mp-1) et leurs méthodes d'utilisation
MX2021005394A (es) 2018-11-07 2021-07-06 Merck Sharp & Dohme Llc Co-formulaciones de anticuerpos anti-gen de activacion de linfocitos 3 (anti-lag3) y anticuerpos anti-muerte programada-1 (anti-pd-1).
US12188063B2 (en) * 2019-02-08 2025-01-07 Institute Of Science Tokyo Enzymatic mutant suitable for homogeneous immunoassay method
US12358986B2 (en) * 2019-03-13 2025-07-15 Merck Sharp & Dohme Llc Anti-cancer combination therapies comprising CTLA-4 and PD-1 blocking agents
SG11202110512WA (en) 2019-03-25 2021-10-28 Alteogen Inc Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection
MX2021012967A (es) * 2019-04-23 2022-01-18 Sanofi Sa Anticuerpos y formulaciones de anti-cd38.
MX2022003432A (es) * 2019-09-23 2022-04-19 Merck Sharp & Dohme Llc Metodos y composiciones que comprenden un anticuerpo monoclonal antictla4 con proteinas de celulas hospederas reducidas y estabilidad del polisorbato-80 aumentada.
KR20220149740A (ko) * 2020-03-05 2022-11-08 머크 샤프 앤드 돔 엘엘씨 Pd-1 길항제, ctla4 길항제 및 렌바티닙 또는 그의 제약상 허용되는 염의 조합물을 사용하여 암을 치료하는 방법
US20220031843A1 (en) * 2020-07-08 2022-02-03 Regeneron Pharmaceuticals, Inc. Stabilized Formulations Containing Anti-CTLA-4 Antibodies
CA3200955A1 (fr) * 2020-11-10 2022-05-19 Sanofi Formulation de conjugue anticorps-medicament ceacam5
US12110330B2 (en) 2021-01-29 2024-10-08 Merck Sharp & Dohme Llc Compositions of programmed death receptor 1 (PD-1) antibodies and methods of obtaining the compositions thereof
WO2023163968A1 (fr) * 2022-02-24 2023-08-31 Merck Sharp & Dohme Llc Formulations stables d'un lieur d'antigène 4 associé aux lymphocytes t cytotoxiques (ctla4) à base de vhh multivalent se liant au ctla4 humain et leurs procédés d'utilisation
CA3250812A1 (fr) * 2022-04-29 2023-11-02 Merck Sharp & Dohme Llc Formulations stables d'anticorps anti-ilt4 ou de fragments de liaison à l'antigène de ceux-ci en combinaison avec des anticorps anti-pd-1 et leurs procédés d'utilisation
CN119894932A (zh) * 2022-07-28 2025-04-25 默沙东有限责任公司 程序性死亡受体1(PD-1)抗体和rHuPH20或其变体或片段的药物组合物
US20260035465A1 (en) * 2022-07-28 2026-02-05 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof

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ES2707284T3 (es) * 2005-03-08 2019-04-03 Pfizer Prod Inc Composiciones de anticuerpo anti-CTLA-4
CN103059138B (zh) * 2005-05-09 2015-10-28 小野药品工业株式会社 程序性死亡-1(pd-1)的人单克隆抗体及使用抗pd-1抗体来治疗癌症的方法
MX2011013722A (es) * 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
CA2769473A1 (fr) * 2009-07-31 2011-02-03 N.V. Organon Anticorps totalement humains diriges contre le btla
CN105296433B (zh) * 2014-08-01 2018-02-09 中山康方生物医药有限公司 一种ctla4抗体、其药物组合物及其用途
EA201792273A1 (ru) * 2015-04-17 2018-04-30 Бристол-Маерс Сквибб Компани Композиции, содержащие комбинацию анти-pd-1 антитела и другого антитела
US9995753B2 (en) * 2015-09-25 2018-06-12 Merck Sharp & Dohme Corp. Anti-pembrolizumab antibodies
MA50501A (fr) * 2017-05-02 2020-09-09 Merck Sharp & Dohme Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation

Also Published As

Publication number Publication date
CO2019012143A2 (es) 2020-01-17
UA129862C2 (uk) 2025-08-27
BR112019022695A2 (pt) 2020-05-26
US20200262922A1 (en) 2020-08-20
CN110678199A (zh) 2020-01-10
EA201992526A1 (ru) 2020-03-13
CN110678199B (zh) 2025-02-28
EP3618866A1 (fr) 2020-03-11
AU2018263837B2 (en) 2025-02-20
MA50501A (fr) 2020-09-09
AU2018263837A1 (en) 2019-12-05
US20250074985A1 (en) 2025-03-06
JP2023109942A (ja) 2023-08-08
KR102624564B1 (ko) 2024-01-12
JP7653465B2 (ja) 2025-03-28
WO2018204343A1 (fr) 2018-11-08
SG11201910134SA (en) 2019-11-28
EP3618866A4 (fr) 2021-07-14
TN2019000294A1 (en) 2021-05-07
KR20190142393A (ko) 2019-12-26
MX2019013034A (es) 2020-02-05
JP2020518598A (ja) 2020-06-25
CA3060695A1 (fr) 2018-11-08

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